Paper analytical devices for fast field screening of beta lactam antibiotics and antituberculosis pharmaceuticals.

Paper analytical devices for fast field screening of beta lactam antibiotics and antituberculosis pharmaceuticals.
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DOI:
10.1021/ac400989p
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发表时间:
2013-07-02
影响因子:
7.4
通讯作者:
Lieberman, Marya
Lieberman, Marya
中科院分区:
化学1区
文献类型:
--
作者:
Weaver, Abigail A.;Reiser, Hannah;Barstis, Toni;Benvenuti, Michael;Ghosh, Debarati;Hunckler, Michael;Joy, Brittney;Koenig, Leah;Raddell, Kellie;Lieberman, Marya

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关于低质量药品的报告在过去十年中一直在增加,不合格药品在发展中国家最普遍,在这些国家,生产质量控制的疏忽或供应链的违规使不合格药品得以进入市场。在这里,我们描述了廉价的测试卡,用于快速现场筛选含有β-内酰胺类抗生素或四种一线抗结核(TB)药物组合的药物剂型。这些设备检测活性药物成分(原料药)氨苄西林、阿莫西林、利福平、异烟肼、乙胺丁醇和吡津酰胺,并筛查可能在假药中发现的替代药物,如对乙酰氨基酚和氯喹。这些测试可以检测出传统层析方法无法显示的粘合剂和填充物,如白垩粉、滑石粉和淀粉。这些纸张设备包含12个通道,由疏水屏障隔开,不同的试剂沉积在通道中。使用者将一些固体药剂擦过通道,并将纸的边缘浸入水中。当水通过毛细作用沿着通道向上爬升时,它会触发不同化学测试的库和一个计时器,以指示测试何时完成。每条车道的反应产生颜色,形成一个可以通过与标准结果进行比较而进行视觉分析的“颜色条形码”。虽然与传统的分析方法相比,原料药的定量很差,但分析物的灵敏度和选择性足够高,足以辨别出不含原料药或替代原料药的可疑配方,以及含有已用非活性成分“切割”的原料药的配方。
Reports of low quality pharmaceuticals have been on the rise in the last decade with the greatest prevalence of substandard medicines in developing countries, where lapses in manufacturing quality control or breaches in the supply chain allow substandard medicines to reach the marketplace. Here, we describe inexpensive test cards for fast field screening of pharmaceutical dosage forms containing beta lactam antibiotics or combinations of the four first-line antituberculosis (TB) drugs. The devices detect the active pharmaceutical ingredients (APIs) ampicillin, amoxicillin, rifampicin, isoniazid, ethambutol, and pyrazinamide, and also screen for substitute pharmaceuticals such as acetaminophen and chloroquine that may be found in counterfeit pharmaceuticals. The tests can detect binders and fillers like chalk, talc, and starch not revealed by traditional chromatographic methods. These paper devices contain twelve lanes, separated by hydrophobic barriers, with different reagents deposited in the lanes. The user rubs some of the solid pharmaceutical across the lanes and dips the edge of the paper into water. As water climbs up the lanes by capillary action, it triggers a library of different chemical tests and a timer to indicate when the tests are completed. The reactions in each lane generate colors to form a “color bar code” which can be analyzed visually by comparison to standard outcomes. While quantification of the APIs is poor compared to conventional analytical methods, the sensitivity and selectivity for the analytes is high enough to pick out suspicious formulations containing no API or a substitute API, as well as formulations containing APIs that have been “cut” with inactive ingredients.
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